17-Oct-2011

Ansell gloves classified as Class III medical devices

Ansell Healthcare has received the CE Mark for its Gammex powder-free gloves with AMT antimicrobial technology, which provide protection against some of the most common pathogens and drug-resistant bacteria.

The firm is launching the gloves across Europe this autumn.

“We look forward to bringing a new level of protection and peace of mind to the surgical staff,” said Peter Dobbelsteijn, senior vice president EMEA, Ansell Healthcare.

“Gammex powder-free with AMT has its own immune system to fight back against pathogens that migrate through the breaches that inevitably occur in actual use.”

The gloves, made from natural rubber latex, provide the same feel, sensitivity, flexibility and dexterity as conventional gloves when manipulating and handling instruments, the firm says. The main difference is the active antimicrobial layer, which contains chlorhexidine gluconate (CHG) and provides ongoing antiviral and antibacterial protection against HIV, hepatitis C and infectious bacteria.

Ansell says the new Gammex powder-free with AMT is a ‘significant technical breakthrough’ in terms of bringing about a change from passive to active protection.

“Glove breaches happen during surgery through the use of sharp instruments and with the AMT technology. Ansell provides for a back-up plan,” said David Lucas, vice president, Science & Technology, Ansell Healthcare.

In clinical and laboratory tests, Gammex powder-free with AMT killed at least 99% of invading HIV and HCV (hepatitis C) surrogate pathogens. In addition, clinical testing has shown that the gloves kill more than 99.7% of eight common infectious bacteria (gram-positive, gram-negative and drug-resistant bacteria) and more than 99.99% of staphylococcus aureus.

These gloves are not proven to protect against blood-borne infections where the skin is broken, cut or punctured.

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